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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K253151

510(k) cleared

Fule Interbody Fusion Cage System

Beijing Fule Science & Technology Development Co., Ltd. · Jun 15, 2026 · K253151

FDA cleared the Fule Interbody Fusion Cage System from Beijing Fule Science & Technology Development Co., Ltd. on Jun 15, 2026 under K253151, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 26, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beijing Fule Science & Technology Development Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K253155 (Fule Metallic Lockable Intramedullary Nail Systems), K252730 (Fule Spinal Fixation System).

Questions & Answers

What did FDA clear under K253151?

K253151 is the FDA 510(k) for Fule Interbody Fusion Cage System, submitted by Beijing Fule Science & Technology Development Co., Ltd.. FDA's decision date was Jun 15, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Fule Interbody Fusion Cage System?

Beijing Fule Science & Technology Development Co., Ltd., based in Beijing, is the applicant of record for K253151.

How long did the K253151 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 15, 2026, 262 days later.

← All decisions in June 2026

Sources